title: Diagnostic accuracy of enhanced liver fibrosis test to assess liver fibrosis in patients with chronic hepatitis C.
abstract: BACKGROUND
  The prognosis and clinical management of patients with chronic liver diseases are closely related to the severity of liver fibrosis. Liver biopsy is considered the gold standard for the staging of liver fibrosis. However, it is an invasive test sometimes related to complications. This study aimed to assess the diagnostic value of enhanced liver fibrosis (ELF) test to predict liver fibrosis in patients with chronic hepatitis C.
  
  
  METHODS
  This study included 162 patients with liver disease and 67 healthy controls. Hyaluronic acid, tissue inhibitor of matrix metalloproteinase type 1, and amino-terminal propeptide type III procollagen were measured by enzyme-linked immunosorbent assay with the ELF test ADVIA Centaur® (Siemens Healthcare Diagnostics Inc.). Fibrosis stage was determined using the Metavir scoring system.
  
  
  RESULTS
  In our study, for the diagnosis of significant fibrosis (Metavir F≥2) a cut-off value >7.72 provides a sensitivity of 93.0% and a specificity of 83.0%. The areas under the receiver operator characteristic curve, sensitivity, specificity, and positive and negative predictive values were 0.94, 93.3%, 81.0%, 93.3%, and 81.0%, respectively (P<0.001). For the diagnosis of cirrhosis (Metavir F=4) a cut-off value >9.3 provides a sensitivity of 93.0% and a specificity of 86.0%. The areas under the receiver operator characteristic curve, sensitivity, specificity, and positive and negative predictive values were 0.94, 79.1%, 90.8%, 75.6%, and 92.3%, respectively (P<0.001).
  
  
  CONCLUSIONS
  The ELF test is a promising non-invasive method for assessing liver fibrosis in patients with chronic hepatitis C. It is effective in the diagnosis of both fibrosis and cirrhosis.
authors.affiliation: Department of Medical and Pediatric Sciences, Institute of Internal Medicine "A. Francaviglia", Section of Gastro-enterology, University of Catania, "G. Rodolico" Hospital, Via S. Sofia, 78-95123-Catania, Italy. rcatanza@unict.it.
authors.forename: Roberto
authors.initials: R
authors.lastname: Catanzaro
authors.forename: Michele
authors.initials: M
authors.lastname: Milazzo
authors.forename: Silvia
authors.initials: S
authors.lastname: Arona
authors.forename: Chiara
authors.initials: C
authors.lastname: Sapienza
authors.forename: Dario
authors.initials: D
authors.lastname: Vasta
authors.forename: Domenico
authors.initials: D
authors.lastname: Arcoria
authors.forename: Francesco
authors.initials: F
authors.lastname: Marotta
mesh_terms: D000328:Adult; D019540:Area Under Curve; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D016022:Case-Control Studies; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications*; D006801:Humans; D006820:Hyaluronic Acid / Q000097:blood*; D008103:Liver Cirrhosis / Q000097:blood / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000097:blood*; D011237:Predictive Value of Tests; D011347:Procollagen / Q000097:blood*; D011379:Prognosis; D011446:Prospective Studies; D012372:ROC Curve; D012720:Severity of Illness Index; D019715:Tissue Inhibitor of Metalloproteinase-1 / Q000097:blood*
chemical_list: D015415:Biomarkers; D010446:Peptide Fragments; D011347:Procollagen; C560822:TIMP1 protein, human; D019715:Tissue Inhibitor of Metalloproteinase-1; C041876:procollagen Type III-N-terminal peptide; D006820:Hyaluronic Acid